NCT03635229

Brief Summary

Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes. Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD. Incidences vary across institutions due to differences in screening and diagnostic tools.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

August 15, 2018

Last Update Submit

October 20, 2023

Conditions

Postoperative DeliriumPostoperative Cognitive Dysfunction

Keywords

cardiac surgeryperioperative carepostoperative deliriumpostoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

    A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period

    Postoperative day 1-5 (5 consecutive days)

Secondary Outcomes (3)

  • Postoperative cognitive dysfunction - postoperative

    Postoperative day 5-9 (5 consecutive days)

  • Postoperative cognitive dysfunction - 3 month

    At 3rd month after hospital discharge

  • Postoperative cognitive dysfunction - 1 year

    At 12th month after hospital discharge

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (age 65 and older) undergoing cardiopulmonary bypass- assisted surgery with anticipated postoperative intensive care unit admission

You may qualify if:

  • age 65 years old or older
  • undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery

You may not qualify if:

  • unable to communicate
  • severe visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Emergence DeliriumPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersCognitive DysfunctionCognition Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

August 21, 2018

Primary Completion

September 26, 2023

Study Completion

December 1, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)